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KHO — Fluorometer, For Clinical Use Class I

FDA Device Classification

Classification Details

Product Code
KHO
Device Class
Class I
Regulation Number
862.2560
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K112161radiometer medical apsAQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, January 20, 2012
K973547biosite incorporatedTRIAGE STATMETERJanuary 13, 1998
K971103tosoh medicsAIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEMJune 27, 1997
K962919johnson and johnson clinical diagnosticsVITROS IMMUNODIAGNOSTIC SYSTEMOctober 18, 1996
K952719biocircuitsBIOCIRCUITS IOS (IN-OFFICE SYSTEM)November 22, 1995
K950415isolabFLUOROSCAN NEONATALSeptember 5, 1995
K935047wallacAUTO DELFIAMay 23, 1994
K930689bio-chem laboratory systemsAUTOBEAD THYROID UPTAKENovember 10, 1993
K926131pb diagnostic systemsOPUS MAGNUM ANALYZERJune 7, 1993
K923021tosohAIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEMJuly 21, 1992
K920888dynatech laboratoriesMICROLITE MICROTITER PLATE LUMINOMETER ML2200March 19, 1992
K913130baxter healthcareSTRATUS IINTELLECT IMMUNOASSAY SYSTEMSeptember 27, 1991
K901674tosohAIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEMMay 2, 1990
K895240pharmaciaDELFIA PLATE FLUOROMETER 1232October 4, 1989
K894159pb diagnostic systemsOPUS IMMUNOASSAY SYSTEMAugust 3, 1989
K890908baxter healthcareSTRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIESMarch 24, 1989
K872803cyberfluorCYBERFLUOR 615 IMMUNOANALYZERSeptember 2, 1987
K871550perkin-elmerPFI-20 POLARIZING FLUORIMETERJuly 1, 1987
K860309helena laboratoriesHEMAFLUOR REAGENT KITJuly 14, 1986
K851984lkb instrumentsLKB-WALLAC 1230 ARCUS FLUOROMETERMay 24, 1985